Study on MK-3475 and Gemcitabine for Treating Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Providence Health & Services

Sponsor score: 40

ClinicalTrials ID:NCT02422381

Provider View

This clinical trial is testing the safety of adding a new investigational drug, MK-3475, to the standard treatment with gemcitabine for patients with advanced non-small cell lung cancer (NSCLC) who have already received treatment. The study also aims to find the best dose of MK-3475 to use with gemcitabine.

Patient Parameters

Program Overview

The study is designed to see if adding MK-3475 to gemcitabine is safe for patients with advanced non-small cell lung cancer (NSCLC) who have already been treated. Researchers will also try to find the best dose of MK-3475 to use with gemcitabine. Participants will receive MK-3475 and gemcitabine over a 21-day cycle for up to 6 cycles. After that, they may continue to receive MK-3475 alone for up to 2 years. The study involves regular clinic visits to monitor for any side effects.

Description

This study is divided into two phases: Phase I and Phase II. In Phase I, the safety of combining MK-3475 with gemcitabine will be evaluated. Participants will receive 200 mg of MK-3475 through an IV infusion every 21 days, along with gemcitabine on Days 1 and 8 of each cycle, for up to 6 cycles. After completing these cycles, participants may continue receiving MK-3475 alone for up to 2 years. Throughout the study, participants will visit the clinic 12 times over 126 days to check for any side effects or signs of drug toxicity. The study aims to determine the best dose of MK-3475 to use with gemcitabine and to ensure the combination is safe for patients.

Eligibility Criteria

Inclusion Criteria

  • Adults with advanced non-small cell lung cancer (NSCLC) that has been confirmed by lab tests.
  • Must have received between one and three previous treatments for advanced cancer.
  • Any side effects from previous treatments should be mild or resolved.
  • Must be in good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Women of childbearing age must have a negative pregnancy test.
  • Must be able to understand the study and agree to participate.
  • Expected to live at least 3 more months.
  • Must have completed any previous experimental treatments at least 3 weeks before joining the study.
  • Must have normal organ and bone marrow function based on blood tests.
  • Must provide a sample of previous tumor tissue for analysis.
  • Must have measurable cancer according to specific criteria.
  • Treated brain metastases are allowed if they are not causing symptoms.
  • Any radiation treatment for symptoms outside the brain must have been completed at least 2 weeks before joining the study.

Exclusion Criteria

  • Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies.
  • Previous treatment with gemcitabine.
  • Previous complications from radiation, such as lung inflammation, that may increase risk with MK-3475.
  • Active autoimmune diseases, except for vitiligo or stable low thyroid function.
  • Currently using steroids, except for non-absorbed treatments like inhalers or skin creams.
  • Active other cancers, except for controlled skin cancer.
  • Positive for HIV or hepatitis B or C.
  • Any other medical or mental health conditions that may make participation unsafe.

Locations

FACILITYZIPCITYSTATE
Providence Oncology & Hematology Care Clinic - Eastside97213PortlandOregon
Providence Oncology & Hematology Care Clinic - Westside97225PortlandOregon

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